Responsible for laboratory testing and coordination of CMC-related activities, with a primary focus on GMP raw materials and critical reagents. Activities will include material qualification and release testing, vendor management, document authorship, and material procurement. Candidate will work with third parties when necessary (e.g., suppliers, CMOs and CTLs). Support of assay development, transfer and validation as needed. The position will provide cross-functional support to quality control, analytical development, process analytics, and other functions.
· Manage outsourced GMP/GLP testing including contract approval, sample management, result tracking and billing.
· Support raw material method development, qualification, transfer and/or validation.
· Perform in-house raw material and critical reagent testing using a variety of analytical and cell based techniques.
· Author controlled GMP documentation including test methods, equipment operation and maintenance, sample management, and specifications.
· Support raw material and critical reagent supplier identification and qualification.
· Manage cross site inventory tracking, production forecasts, and pre-qualification activities.
· Coordinate onboarding and ongoing management of GMP service providers.
· Support analytical development, quality control and process analytics groups as needed.
· B.S. in Biochemistry, chemical engineering, biology or chemistry.
· 5+ years of laboratory experience in raw material, quality control, process development, or analytical development roles.
· Diverse laboratory experience in one or more of the following areas (HPLC, LC-MS, Cell Biology, Molecular Biology, or protein characterization assays.
· Authorship of controlled GMP/GLP documentation including specifications, SOPs and test methods.
· Experience managing outsourced contract services and projects.
· Ability to work under tight timelines and effectively communicate to internal stakeholders and external partners.
· Experience in GMP raw material qualification, release and stability testing.
· Knowledge of raw material FDA regulations and USP/ICH guidelines.
· Familiarity with supply chain and procurement operations.
· Understanding and experience performing assay validation.
· Experience operating in early stage clinical to commercial environments.